SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures. HPV-positive oropharyngeal cancer patients have a much better prognosis that their HPV-negative counterparts. Despite this, Post Treatment Surveillance (PTS) strategy does not take into account HPV status. HPV Circulating DNA (HPV Ct DNA) has emerged as a promising tool to assess the risk of cancer recurrence following treatment. We assume that this biomarker could be helpful to guide PTS. The number of systematic PTS visits could be significantly reduced in patients with undetectable HPV Ct DNA whereas a closer clinical and radiological follow up could be performed in case of detectable HPV Ct DNA. If confirmed, this new strategy could have several benefits including: * reduction of PTS visits for most HPV-positive patients which implies a potential cost decrease and * Identification of relapse at early stages (before the occurrence of symptoms)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
420
Droplet based digital PCR (ddPCR) technology is a novel method for performing digital PCR. A sample is fractionated into 20,000 droplets, PCR amplification of the template molecules occurs in each individual droplet. ddPCR allows to generate quantitative and accurate data without standard curves and also present higher sensitivity compared to conventional quantitative PCR (qPCR). Indeed, this method is based on the realization of millions of single-molecule PCRs in parallel in independent compartment (here droplets of an emulsion) and consequently avoids the bias seen in conventional PCR. ddPCR offers an optimized approach for the sensitive detection and quantification of low-target-abundance biological samples. DNA extraction will be planned on 1 mL of plasma, which will further increase the sensitivity of our technique initially based on only 200µL of DNA extracted plasma.
Clinique St Vincent- Réunion
Saint-Denis, La Réunion, France
ACTIVE_NOT_RECRUITINGISC Avignon
Avignon, France
RECRUITINGGeorges-François Leclerc
Dijon, France
RECRUITINGOscar Lambret- Lille
Lille, France
NOT_YET_RECRUITINGLa Timone-AP-HM Marseille
Marseille, France
RECRUITINGAntoine Lacassagne - NICE
Nice, France
ACTIVE_NOT_RECRUITINGCHU De Nîmes ICG
Nîmes, France
ACTIVE_NOT_RECRUITINGHôpital Européen Georges Pompidou
Paris, France
RECRUITINGInstitut Curie - Paris
Paris, France
NOT_YET_RECRUITINGTENON - APHP Paris
Paris, France
RECRUITING...and 6 more locations
Negative Predictive Value (NPV) of HPV16 ct-DNA
The presence of HPV16 ct-DNA will be evaluated by ddPCR. NPV will be defined as 2 successive HPV16 ct-DNA negative results.
Time frame: 24 months
5- year Negative Predictive Value
The presence of HPV16 ct-DNA will be evaluated by ddPCR. NPV will be defined as 2 successive HPV16 ct-DNA negative results.
Time frame: 48 and 60 months
Positive Predictive Value (PPV) of HPV16 ct-DNA
The presence of HPV16 ct-DNA will be evaluated by ddPCR. PPV will be defined as 2 successive HPV16 ct-DNA positive results.
Time frame: 18, 24, 48, and 60 months
Rate of relapses detected by HPV16 ct-DNA
The proportion of patients with relapse detected by HPV16 ct-DNA without any other symptoms.
Time frame: 5.5 years
Disease-free survival
Disease-free survival (DFS) is defined as the delay between date of inclusion and tumor relapse (local, regional, or distant) or death from any cause, whichever occurs first.
Time frame: 5.5 years
Loco-Regional recurrence
Evaluation of the stage of the first loco-regional event detected by medical imaging. The stage will be defined by the size of the tumor and the number of invaded lymph nodes.
Time frame: From randomization to disease recurrence, up to 5.5 years
Time of distant recurrence
The length of time until manifestation of the first metastatic event detected by medical imaging.
Time frame: From randomization to disease recurrence, up to 5.5 years
Overall survival
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Time frame: From randomization to death from any cause, up to 5.5 years
Cost-effectiveness analysis of the proposed strategy
To evaluate the economic cost of the lightened surveillance as compared to the standard treatment in terms of cost assessments and incremental cost-effectiveness ratio.
Time frame: 5.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.